Amlitelimab phase 3 results guide Sanofi (NASDAQ: SNY) AD plans
Rhea-AI Filing Summary
Sanofi reported new late-stage clinical results for amlitelimab, an experimental antibody targeting OX40-ligand for patients 12 and older with moderate-to-severe atopic dermatitis.
Two global phase 3 trials, SHORE and COAST 2, showed that amlitelimab given every four or twelve weeks improved skin clearance and disease severity at Week 24 versus placebo on key measures such as vIGA-AD 0/1 and EASI-75, with a safety profile similar to placebo in both studies. In COAST 2, amlitelimab met the primary endpoint for the US estimand but did not achieve statistical significance on co-primary endpoints for the EU estimand.
A preliminary analysis of the open-label ATLANTIS phase 2 study showed progressive improvement in vIGA-AD 0/1 from 35.4% at Week 24 to 50.3% at Week 52 and EASI-75 from 62.9% to 76.5%, with low discontinuations and serious adverse events. Sanofi plans global regulatory submissions for amlitelimab in the second half of 2026, while emphasizing that the drug remains under clinical development and is not yet approved.
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Insights
Late-stage amlitelimab data strengthen Sanofi's atopic dermatitis program but show regional differences in efficacy.
Amlitelimab generated a substantial phase 3 data package in moderate-to-severe atopic dermatitis. In SHORE, where patients also used topical corticosteroids, both every-4-week and every-12-week dosing met all primary and key secondary endpoints versus placebo at Week 24 on vIGA-AD 0/1 and EASI-75, giving a strong randomized evidence base with combination therapy and flexible dosing.
COAST 2, a monotherapy trial, met the vIGA-AD 0/1 primary endpoint for the US estimand, but the EU estimand co-primary endpoints did not reach statistical significance, which limits formal interpretation of some secondary results. Across SHORE and COAST 2, overall adverse event, serious event, and discontinuation rates were similar to placebo, supporting a tolerability profile that aligns with prior data.
The ATLANTIS open-label study adds longer-term context, with vIGA-AD 0/1 rising from
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2026
Commission File Number: 001-31368
SANOFI
(Translation of registrant’s name into English)
46, avenue de la Grande Armée, 75017 Paris, FRANCE
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
1
In January 2026, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein by reference.
Exhibit Index
| Exhibit No. | Description | |
| Exhibit 99.1 | Press Release dated January 23, 2026: Sanofi’s amlitelimab confirms its potential in atopic dermatitis | |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Dated: January 23, 2026 | SANOFI | |||||
| By | /s/ Alexandra Roger | |||||
| Name: Alexandra Roger | ||||||
| Title: Head of Legal Corporate & Finance | ||||||
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Exhibit 99.1
| Press Release |
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Sanofi’s amlitelimab confirms its potential in atopic dermatitis
| • | In the SHORE phase 3 study, amlitelimab in combination with topical therapies met all primary and key secondary endpoints at Week 24 with efficacy progressively increasing throughout the treatment period with some patients improving as early as Week 2 |
| • | In the COAST 2 phase 3 study, amlitelimab demonstrated statistically significant efficacy on vIGA-AD 0/1, the primary endpoint as assessed for the US and US reference countries, and confirmed COAST 1 potential for Q12W dosing from the start; amlitelimab did not achieve statistical significance for the co-primary endpoints as assessed for the EU and EU reference countries |
| • | Based on the totality of data, Sanofi will move forward with global regulatory submissions for amlitelimab |
| • | A preliminary analysis of the ATLANTIS phase 2 study showed continued and progressive improvements with no evidence of plateau through Week 52, demonstrating the potential of OX40-ligand as an important new mechanism in AD |
Paris, January 23, 2026. Following the positive COAST 1 (clinical study identifier: NCT06130566) results in September 2025, two additional global phase 3 studies – SHORE (clinical study identifier: NCT06224348) and COAST 2 (clinical study identifier: NCT06181435) – of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L), today delivered a robust body of evidence that supports amlitelimab’s potential in the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis (AD). In these two phase 3 studies amlitelimab was well-tolerated and the safety profile was consistent with previously reported data.
“Importantly, these results validate amlitelimab’s novel mechanism of action to block OX40-ligand without T-cell depletion and its promise to normalize the immune system over time,” said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi. “The totality of data seen to date reinforce our confidence in amlitelimab’s potential to deliver both Q12W dosing from the start and progressive efficacy through Week 52. We look forward to sharing additional results, including longer-term data, as we move toward global regulatory submissions.”
For both SHORE and COAST 2 phase 3 studies, key endpoints were measured at Week 24 in patients aged 12 years and older with moderate-to-severe AD who received amlitelimab either every four weeks (Q4W) or every 12 weeks (Q12W). For US and US reference countries, the single primary endpoint was the proportion of patients with a validated investigator global assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline score of ≥2 points, analyzed using non-responder imputation (US estimand). For the EU, EU reference countries and Japan, the co-primary endpoints comprised the proportion of patients with vIGA-AD 0/1 and a reduction from baseline score of ≥2 points along with the proportion of patients reaching a 75% or greater improvement in the eczema area and severity index total score (EASI-75), both analyzed using treatment policy (EU estimand).
SHORE study
In the SHORE study, amlitelimab, dosed either Q4W or Q12W in conjunction with medium-potency background topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI), met all primary and key secondary endpoints compared to placebo plus TCS with or without TCI at Week 24, across both US and EU estimands.
SHORE primary endpoints
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| Key endpoints Proportion of patients |
Non-responder imputation*+ (US estimand) |
Treatment policy**+ (EU estimand) | ||||||||||
| Q4W | Q12W | Placebo | Q4W | Q12W | Placebo | |||||||
|
vIGA-AD 0/1 |
28.7% p-value (p) p≤0.01 |
32.3% p≤0.01 |
16.8% | 29.9% p≤0.01 |
32.9% p≤0.01 |
16.8% | ||||||
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EASI-75 |
48.1% p≤0.01 |
46.8% p≤0.025 |
32.3% | 50.9% p≤0.001 |
48.1% p≤0.025 |
34.2% | ||||||
* Non-responder imputation (NRI): patients with rescue or prohibited medication use before Week 24 or with missing efficacy assessments at Week 24 are classified as non-responders.
** Treatment policy: all data are included regardless of rescue medication use prior to Week 24. Patients with prohibited medication use before Week 24 or with missing efficacy assessments at Week 24 are classified as non-responders.
+ Statistical analyses followed a pre-specified hierarchical testing procedure to control for multiplicity. For the pre-specified endpoints across the two doses, the statistical significance level was adjusted (alpha-split) to two-sided p<0.025.
COAST 2 study
In the COAST 2 study, amlitelimab monotherapy dosed either Q4W or Q12W met the primary endpoint of the proportion of patients achieving vIGA-AD 0/1 and a reduction from baseline score of ≥2 points compared to placebo at Week 24, as assessed for the US and US reference countries. The key secondary endpoint of the proportion of patients who achieved vIGA-AD 0/1 with barely perceptible erythema (BPE), as assessed for the US and US reference countries, did not achieve statistical significance. For the EU and EU reference countries, amlitelimab dosed either Q4W or Q12W did not achieve statistical significance for the co-primary endpoints of proportion of patients achieving vIGA-AD 0/1 and EASI-75 compared to placebo. Therefore, in accordance with hierarchical statistical testing procedures, p-values presented below for additional secondary endpoints reflect nominal significance without adjustment for multiplicity.
| COAST 2 primary endpoints | ||||||||||||
| Key endpoints Proportion of patients |
Non-responder imputation*+ (US estimand) |
Treatment policy**+ (EU estimand) | ||||||||||
| Q4W | Q12W | Placebo | Q4W | Q12W | Placebo | |||||||
|
vIGA-AD 0/1 |
25.3% p≤0.025 |
25.7% p≤0.025 |
14.8% | 28.8% p=0.031 |
27.7% p=0.068 |
18.8% | ||||||
|
EASI-75 |
41.8% p≤0.001*** |
40.5% p≤0.01*** |
24.2% | 49.7% p≤0.001*** |
45.9% p≤0.01*** |
30.2% | ||||||
* Non-responder imputation (NRI): patients with rescue or prohibited medication use before Week 24 or with missing efficacy assessments at Week 24 are classified as non-responders.
** Treatment policy: all data are included regardless of rescue medication use prior to Week 24. Patients with prohibited medication use before Week 24 or with missing efficacy assessments at Week 24 are classified as non-responders.
+ Statistical analyses followed a pre-specified hierarchical testing procedure to control for multiplicity. For the pre-specified endpoints across the two doses, the statistical significance level was adjusted (alpha-split) to two-sided p < 0.025. Nominal p-values <0.05 are also reported.
*** P-values are nominal without multiplicity adjustment.
The most common treatment-emergent adverse events (TEAEs) in SHORE (≥5% in any dose arm; pooled amlitelimab vs. placebo) were nasopharyngitis (9.5% vs 12.5%), upper respiratory tract infection (7.9% vs 4.4%), dermatitis atopic (2.7% vs 5.6%). Overall, rates of TEAEs, serious adverse events, and TEAEs resulting in treatment discontinuation were similar in the pooled amlitelimab arms and placebo arm.
The most common TEAEs in COAST 2 (≥5% in any dose arm; pooled amlitelimab vs. placebo) were nasopharyngitis (5.9% vs 7.4%), upper respiratory tract infection (4.8% vs 4.0%), dermatitis atopic (5.3% vs 2.7%). Overall, rates of TEAEs, serious adverse events, and TEAEs resulting in treatment discontinuation were similar in the pooled amlitelimab and placebo arms.
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Preliminary analysis from ATLANTIS phase 2 open-label study
In addition, a preliminary analysis of the ongoing, open-label ATLANTIS phase 2 study (clinical study identifier: NCT05769777) indicated that amlitelimab dosed Q4W progressively improved skin clearance and disease severity beyond Week 24 to Week 52 in 591 patients aged 12 years and older with moderate-to-severe AD. In this preliminary analysis, amlitelimab was well-tolerated through Week 52.
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ATLANTIS preliminary analysis |
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| Key endpoints | Proportion of patients | |||
| Week 24 | Week 52 | |||
|
vIGA-AD 0/1 |
35.4% | 50.3% | ||
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EASI-75 |
62.9% | 76.5% | ||
Patients with missing data are classified as non-responders. Concomitant use of TCS with or without TCI is allowed as needed2. Short-term (<4 weeks) oral corticosteroids rescue therapy is permitted.
The most common TEAEs in this preliminary analysis of ATLANTIS (≥5%) were nasopharyngitis (19.1%), headache (10.3%), influenza (9.1%), dermatitis atopic (8.6%), upper respiratory tract infection (7.2%) and accidental overdose (5.1%, due to dose scheduling). Serious TEAEs and TEAEs resulting in treatment discontinuation at Week 52 were low, 4.7% and 2.9% respectively. In addition, an event of Kaposi’s sarcoma, determined to be cutaneous, was reported in a patient with known risk factors. The patient stopped amlitelimab and is in the recovery phase.
Results for COAST 1, COAST 2, SHORE, and this preliminary analysis of ATLANTIS will be presented at forthcoming medical congresses.
Two additional phase 3 studies, AQUA (clinical study identifier: NCT06241118) and ESTUARY (clinical study identifier: NCT06407934) are anticipated to report results in H2 2026. Global regulatory submissions are planned for H2 2026, unchanged.
Amlitelimab is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
About the SHORE study
SHORE was a randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter phase 3 study to evaluate the efficacy and safety of amlitelimab in combination TCS with or without TCI in 596 participants aged 12 years and older with moderate-to-severe AD. Key objectives include measuring the efficacy and safety of amlitelimab compared to placebo at Week 24 when used in combination with TCS/TCI. In the study, amlitelimab was administered at a dose of 250 mg (125 mg for those with body weight <40 kg) on either a Q4W or Q12W schedule following a loading dose of 500 mg (250 mg for those with body weight <40 kg). Patients were given medium-potency TCS/TCI, applied up to twice daily to treat active lesions, and were instructed to reduce the dose to three times weekly or discontinue use based on lesion control or clearance. The study included sites across the North America, EU, Argentina, Chile, Brazil, Turkey, Canada, China, and Japan.
About the COAST 2 study
COAST 2 was a randomized, double-blind, placebo-controlled, parallel-group, 3-arm, global, multicenter phase 3 study to evaluate the efficacy and safety of amlitelimab monotherapy in 547 adults and adolescents aged 12 years and older with moderate-to-severe AD. Key objectives included measuring the efficacy and safety of amlitelimab compared to placebo at Week 24. In the study, amlitelimab was administered at a dose of 250 mg (125 mg for those with body weight <40 kg) on either a Q4W or Q12W schedule following a loading dose of 500 mg (250 mg for those with body weight <40 kg). The study included sites across the US, EU, United Kingdom, Argentina, Chile, Mexico, South Africa, Turkey, China, and Japan.
About the ATLANTIS study
ATLANTIS is a phase 2 global, single-arm, open-label, long-term safety study of amlitelimab for the treatment of patients 12 years or older with moderate to severe atopic dermatitis (AD) with
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a duration of up to 268 weeks. In the study, patients received weight-based amlitelimab Q4W (250 mg [125 mg for those with body weight <40 kg] following a loading dose of 500 mg [250 mg for those with body weight <40 kg]). The primary outcome measures of the ATLANTIS study are the percentage of participants who experienced TEAEs and TESAEs from baseline. Efficacy outcome measures included the proportion of patients with a vIGA-AD 0/1 and the proportion of participants achieving EASI-75. The study has enrolled 963 patients to date and includes sites across North America, Latin America, EU, United Kingdom, Turkey, South Africa, India, Australia, South Korea, Taiwan, China, and Japan.
About amlitelimab
Amlitelimab (SAR445229, KY1005) is a fully human, non-T cell depleting monoclonal antibody that blocks the OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab selectively blocks OX40L signaling during the inflammatory prequel, the initiating phase of an overactive immune system, to potentially normalize T-cell-mediated inflammation without T-cell depletion.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group.
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FAQ
What did Sanofi (SNY) announce about amlitelimab in atopic dermatitis?
Sanofi reported that amlitelimab, a monoclonal antibody targeting OX40-ligand, produced positive late-stage results in moderate-to-severe atopic dermatitis, with two phase 3 trials (SHORE and COAST 2) and a phase 2 study (ATLANTIS) showing clinically meaningful skin clearance and disease improvement along with a safety profile similar to placebo.
How did amlitelimab perform in the SHORE phase 3 study reported by Sanofi (SNY)?
In SHORE, amlitelimab given every four or twelve weeks with background topical corticosteroids met all primary and key secondary endpoints versus placebo at Week 24. Proportions of patients achieving vIGA-AD 0/1 and EASI-75 were consistently higher in the amlitelimab arms than in the placebo arm under both the US and EU estimands.
What were the key findings from the COAST 2 phase 3 amlitelimab trial?
COAST 2 evaluated amlitelimab monotherapy every four or twelve weeks. For the US estimand, amlitelimab met the primary endpoint of vIGA-AD 0/1 with a ≥2-point improvement versus placebo at Week 24. For the EU estimand, the co-primary endpoints of vIGA-AD 0/1 and EASI-75 did not achieve statistical significance compared with placebo, so subsequent p-values are described as nominal.
What long-term data did Sanofi provide from the ATLANTIS amlitelimab study?
A preliminary analysis of ATLANTIS, an open-label phase 2 study, showed that amlitelimab dosed every four weeks improved outcomes through Week 52 in 591 patients. The proportion with vIGA-AD 0/1 increased from
What safety profile did Sanofi (SNY) report for amlitelimab in these studies?
Across SHORE and COAST 2, the most common treatment-emergent adverse events included nasopharyngitis, upper respiratory tract infection, and atopic dermatitis, with similar overall rates of adverse events, serious events, and discontinuations in amlitelimab and placebo arms. In ATLANTIS, common events included nasopharyngitis, headache, influenza, atopic dermatitis, respiratory infections, and accidental overdose related to dosing schedule, with low serious adverse event and discontinuation rates.
When does Sanofi plan to file for amlitelimab approval?
Sanofi states that global regulatory submissions for amlitelimab in atopic dermatitis are planned for
What future amlitelimab data readouts did Sanofi (SNY) highlight?
Sanofi indicated that results from two additional phase 3 studies, AQUA (NCT06241118) and ESTUARY (NCT06407934), are anticipated in
